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DRUG RECALLMODERATE
Curosurf (poractant alfa) 240 mg Intratracheal Suspension
Chiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
What to do
Do not use this product. Contact Chiesi USA, Inc. immediately for instructions on return or disposal. Consult your healthcare provider regarding alternative treatment options.
Why it was recalled
Lack of Assurance of Sterility
How to identify it
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification